BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOPLEX II FACET S

    MDR report key: 12473835 · Received September 15, 2021

    Report

    Report Number
    12473835
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 6, 2021
    Report Date
    September 3, 2021
    Product Code
    BSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT, ADMITTED TO THE OR, HAVING LEFT-SIDED RS AND TAP BLOCK FOR LAPAROSCOPIC LIVER SURGERY. THE PAJUNK GMBH MEDIZINTECHNOLOGIE SONOPLEX II FACET S 22G/80MM NERVE BLOCK NEEDLE APPEARS TO HAVE MALFUNCTIONED (REF # (B)(4), LOT #1394.10). THE NEEDLE WAS PRE-PRIMED WITH MEDICATION AND TUBING WAS ATTACHED TO A 30ML SYRINGE. NEEDLE WAS GUIDED INTO THE CORRECT POSITION. ASPIRATION WAS NEGATIVE. NEEDLE WOULD NOT INJECT. TUBING WASN'T KINKED. NO EVIDENCE OF DEBRIS IN SYRINGE. MULTIPLE CARE GIVERS ATTEMPTED TO DEPRESS THE PLUNGER ON THE SYRINGE WITHOUT SUCCESS. NEEDLE WAS WITHDRAWN AND REPLACED WITH A NEW DEVICE. BLOCK WAS COMPLETED SUCCESSFULLY. DEVICE AND PACKAGING HAVE BEEN SAVED. THIS IS A CONTAMINATED SHARP THAT IS SHEATHED. ITEM CAN BE PROVIDED TO MATERIALS IF NEEDED. THIS IS THE SECOND TIME THIS EXACT INCIDENT WITH THIS PRODUCT HAS OCCURRED AT THE MEDICAL CENTER. WRITING THE REPORT SO IT CAN BE TRACKED IF IT HAPPENS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371171 SONOPLEX II FACET S NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP 001287-71 1394.10

    Patients

    Seq Age Sex Outcome Treatment
    1